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When used without cement, CD Horizon™ Fenestrated Screws (with or without Sextant™ or Longitude™ instrumentation) are intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD- defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tumor and/or trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), pseudarthrosis, and/or failed previous fusion.

Additionally, CD Horizon™ Fenestrated Screws may be used for immobilization and stabilization when used for trauma (e.g., fracture or dislocation) with the usage of bone graft material left to the surgeon's discretion.

When used in conjunction with Kyphon™ HV-R™ Bone Cement or Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD Horizon™ Fenestrated Screws augmented with Kyphon™ HV-R™ Bone Cement or Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.

With the exception of DDD, the CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of the Vertex™ indications of use.

Kyphon™ HV-R™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathological fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

When used in conjunction with CD Horizon™ Fenestrated Screws, Kyphon™ HV-RTM Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD Horizon™ Fenestrated Screws augmented with Kyphon™ HV-RTM Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC™ Powerease™ System. Do not implant the instruments.

IPC™ System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures. The IPC™ Powerease™ System is indicated for drilling, tapping and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods. Do not implant the instruments.

CD Horizon™ Fenestrated Screw Set: The CD Horizon™ Fenestrated Screw Set consists of a variety of cannulated screws. These screws contain a series of fenestrations which allows polymethylmethacrylate (PMMA) bone cement (Kyphon™ HV-R™ Bone Cement or Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement) to be injected into the treated site. This cement is used to augment screw fixation into the pedicle in patients whose life expectancy is of insufficient duration to permit achievement of fusion. These implants may also serve as traditional pedicle screws when used without bone cement in patients. CD Horizon™ Fenestrated Screws are specifically designed to connect to appropriate rods and associated connecting components contained within the CD Horizon™ Spinal System. CD Horizon™ Fenestrated Screw Set implant components are fabricated from medical grade titanium and/or medical grade titanium alloy and/or medical grade cobalt-chromiummolybdenum alloy.

CD Horizon™ Spinal System: The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for various spinal conditions. The system includes titanium, cobalt chrome, and stainless steel implants, as well as PEEK rods and the Spire™ plate. The system can be used with autograft and/or allograft.

Kyphon™ HV-R™ Bone Cement: Kyphon™ HV-R™ Bone Cement is a polymethylmethacrylate (PMMA) that contains approximately 30% barium sulfate. It is designed for delivery in a highly viscous state. It is provided sterile in two components: 20 grams of powder and nine grams of liquid. The powder contains methylmethacrylatestyrene co-polymer, barium sulfate, and benzoyl peroxide. The liquid contains methylmethacrylate (monomer), hydroquinone and N, N dimethyl-p-toluidine.

Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ Powerease™ Systems: Medtronic Navigated Reusable Instruments are spine preparation instruments made of high grade stainless steel. They are designed for use with the StealthStation™ Image Guidance System to track the instruments in the surgical field. They are also compatible with Medtronic's IPC™ Powerease™ System.

Medtronic Reusable Instruments for use with the IPC™ Powerease™ System: The Medtronic Reusable Instruments compatible with Medtronic's IPC™ Powerease™ System are spine preparation instruments, manufactured from materials commonly used in orthopedic procedures. They can be connected to the Powerease™ Driver or used manually and are compatible with various Medtronic spinal implant systems.

The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of AI/ML or diagnostic performance.

The document is a 510(k) summary for several medical devices: CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, and Kyphon™ HV-R™ Bone Cement. It primarily focuses on demonstrating substantial equivalence to predicate devices through design descriptions, indications for use, and a general statement about performance data.

Here's why the requested information cannot be extracted:

• No AI/ML Component: The devices described are spinal implants and bone cement, along with surgical instruments. There is no mention of any artificial intelligence or machine learning component.
• No Diagnostic Performance Data: The document discusses the mechanical and material equivalence of the devices to existing ones, and their indications for use in surgical procedures. It does not contain any data related to diagnostic performance metrics like sensitivity, specificity, AUC, or F1 score.
• No Clinical Study for Performance Metrics (as requested): While "performance data" is mentioned (Section VI), it refers to mechanical testing (ASTM F1798 and ASTM F1717) for spinal systems, not clinical trials or studies to evaluate diagnostic accuracy or AI model performance. It states that these mechanical tests "met the pre-determined acceptance criteria," but these criteria are for physical properties, not diagnostic accuracy.

Therefore, since the device is a physical medical implant/instrument and not an AI/ML diagnostic software, the requested information elements (acceptance criteria table related to diagnostic performance, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, training set ground truth) are not applicable to this document.

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The Navigated Disc Preparation Instruments are intended to facilitate a discectomy or boney resection during spinal surgery. The Navigated T2 Stratosphere templates are intended to facilitate size selection of vertebral body replacement devices during spinal surgery. The Navigated Capstone™ Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. When the Navigated Rotating Shavers are used as trials for Elevate™ Spinal System, they are intended to facilitate implant size selection. The Navigated Probe is intended to be used during pedicle preparations. The Navigated Inserters are intended to be used for the placement of an implant.

Navigated instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Navigated Anterolateral Disc Prep Instruments are made of high-grade stainless steel as the predicate, per ASTM F899. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate to facilitate a discectomy or boney resection during spinal surgery. The instruments are compatible with Medtronic NavLock trackers and Medtronic single-use sterile spheres to allow a Medtronic computer-assisted surgery system such as the StealthStation® Image Guidance System to track the instruments in the surgical field.

This document describes the regulatory clearance for the Navigated Anterolateral Disc Prep Instruments designed for use with the Medtronic StealthStation™ System.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document provides a summary of performance testing but does not explicitly state numerical acceptance criteria or detailed reported device performance in a table format. However, it lists the types of tests conducted and their descriptions. The "reported device performance" is generally implied as passing the tests to ensure functionality and compatibility.

2. Sample size used for the test set and the data provenance:

The document does not specify the sample size for any of the tests conducted. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature) for the test sets. These details are typically provided in more comprehensive study reports or validation documentation, which are not fully contained within this FDA 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not provide information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for the test sets. The tests described (e.g., navigation accuracy, simulated use, CAD model evaluation) suggest engineering and technical evaluations rather than clinical expert reviews for ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

The document does not describe any adjudication method for the test set. Given the nature of the tests (functional and technical evaluations), formal adjudication methods like those used in clinical trials for expert-based ground truth might not be applicable or were not deemed necessary to be included in this summary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. The device described is a set of navigated surgical instruments, not an AI-assisted diagnostic or interpretative system where "human readers" would be involved in interpreting data that the device processes. Therefore, this question is not applicable to the device under review.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device is a set of physical surgical instruments designed to be used with a navigation system (StealthStation™) and operated by a human surgeon. It is not an algorithm-only or standalone AI system. Therefore, the concept of "standalone (algorithm only)" performance without human intervention is not applicable to this device. The navigation system itself might undergo separate standalone performance testing, but this document focuses on the instruments.

7. The type of ground truth used:

The "ground truth" for the tests described appears to be based on:

• Engineering specifications and design requirements: For tests like "Navigation Accuracy Analysis," "CAD Model Evaluation," and "Spine Tools Package Functional Testing," the ground truth would be precise engineering measurements, CAD model data, and software interface requirements.
• Intended use functionality validation: For "Navigation Simulated Use" and "Verification & Validation," the ground truth involves confirming that the instruments perform as expected and meet their intended functional objectives.
• Material standards: For "Biocompatibility," the ground truth is adherence to established ASTM material standards.

8. The sample size for the training set:

The document does not mention a training set as this device is not an AI/machine learning system that requires model training. The tests described are related to the physical and functional performance of surgical instruments.

9. How the ground truth for the training set was established:

As there is no training set for this type of device, this question is not applicable.

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The Choice Spine Navigation reusable instruments are intended to be used during preparation and placement of Choice Spine Lancer™ and Thunderbolt™ system screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Choice Spine Navigation reusable instruments are specifically designed for use with the Medtronic® StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Choice Spine Navigation instruments are non-sterile, reusable instruments designed to function with the Medtronic® StealthStation® System and SureTrak® II System. The Choice Spine Navigation instruments are for use with Choice Spine pedicle screw systems, specifically, the Lancer™ and Thunderbolt™ Pedicle Screw Systems. The instruments are manufactured from medical grade titanium and stainless steel.

The provided text describes a 510(k) premarket notification for the "Choice Spine Navigation System." This submission focuses on establishing substantial equivalence to a predicate device, rather than proving the device's absolute performance against a set of de novo acceptance criteria through extensive clinical studies, as might be required for a PMA or novel device.

The context of a 510(k) submission means the "device performance" and "acceptance criteria" are viewed through the lens of demonstrating equivalence to a legally marketed predicate. Therefore, the "study" proving it meets acceptance criteria is primarily an engineering and non-clinical performance assessment against a recognized standard (ASTM F2554-10).

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for a 510(k) is substantial equivalence to a predicate device. This is demonstrated by showing that the new device has "nearly identical technological characteristics" and that any minor differences "do not raise any new issues of safety and effectiveness."

The specific performance testing mentioned is for positional accuracy, as this is a critical function of a surgical navigation system.

Important Note: The provided text is a summarization for FDA submission. It generally does not include the detailed numerical results from performance tests; instead, it states the conclusion that the performance was "sufficient for its intended use" and "substantially equivalent." Full test reports would contain the exact measurements.

Additional Information on the Study (Based on 510(k) Context)

Given this is a 510(k) submission, the "study" proving the device meets acceptance criteria is primarily a non-clinical performance study and comparison to predicates.

1. Sample sizes used for the test set and the data provenance:

   • The document explicitly states "non-clinical testing" and references ASTM F2554-10. This standard typically involves laboratory-based measurements rather than human patient data.
   • Therefore, the "test set" would consist of physical test setups or mock anatomy used to measure positional accuracy according to the ASTM standard.
   • No specific sample size for "cases" is mentioned, as it's not a clinical study on patients. The "sample size" would relate to the number of measurements taken during the laboratory testing according to the standard.
   • Data Provenance: The testing was conducted by Choice Spine, LP., based in the USA. It's non-clinical/bench testing, not retrospective or prospective patient data from specific countries.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For non-clinical performance testing like positional accuracy per ASTM F2554-10, expert consensus in the form of physical measurement standards and calibrated equipment establishes the "ground truth." There are no human experts adjudicating clinical images or outcomes.
   • The "experts" involved would be engineers and technicians trained in metrology and the use of the specified testing equipment (e.g., optical tracking systems, coordinate measuring machines) to perform the measurements according to the standard. Their qualifications would be in engineering and quality assurance/testing.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable in this context. Adjudication methods like 2+1 or 3+1 are used for human expert interpretation of clinical data (e.g., medical images) to establish a consensus ground truth.
   • For non-clinical performance testing, the "ground truth" is derived from calibrated measurement devices and the precise execution of a standardized testing protocol (ASTM F2554-10). The results are quantitative measurements.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC study was not conducted for this submission.
   • This device is a surgical navigation system, not an AI-assisted diagnostic imaging device. Its function is to guide physical instruments in real-time during surgery, not to interpret images or assist "human readers" in a diagnostic context.
   • Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this device's intended use and assessment.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The device itself is standalone in its measurement capability, but its intended use is inherently human-in-the-loop, assisting a surgeon.
   • The "performance" tested (positional accuracy) reflects the algorithm's ability to track and display positions accurately. This test is a standalone assessment of the system's mechanical and computational accuracy, independent of a specific surgical procedure or patient.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth for the positional accuracy testing is based on metrological standards and precise physical measurements obtained from calibrated equipment according to ASTM F2554-10.
   • It is not expert consensus on clinical findings, pathology, or patient outcomes data.

7. The sample size for the training set:

   • Not applicable. This device is hardware and software for surgical navigation. It's not described as an AI/machine learning device that requires a "training set" of data in the typical sense (e.g., for image classification or prediction).
   • Its functionality is based on established engineering principles (e.g., optical tracking, coordinate systems) and algorithms, not data-driven machine learning models that learn from a "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" in the context of machine learning for this device.

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Medtronic Surgical Instruments are intended to be used during the preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the MAZOR X Stealth™ Edition, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Arm Guide. Medtronic surgical drills shall only be used through the MAZOR X arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ POWEREASE™ System. An instrument may incorporate a measuring function which has uses as described on the label and the instrument.

DO NOT IMPLANT THE INSTRUMENTS

The CD HORIZON™ Spinal System surgical instruments are non-sterile, single or re-usable instruments that may be used during the preparation and placement of various Medtronic spinal implants during spinal surgery. The subject instruments are made of a variety of materials commonly used in orthopedic and neurological procedures which meet available national or international standards specifications. Single-use Medtronic Surgical instruments should never be reused under any circumstances.

The CD HORIZON™ instruments are specifically designed for use in spinal procedures with MAZOR X Stealth™ Edition. The instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Arm Guide. Some instruments (e.g. drills, drivers, taps etc.) are also compatible with Medtronic's IPC™ POWEREASE™ System when connected to the POWEREASE™ Driver, these CD HORIZON™ instruments may or may not be guided through the MAZOR X Arm Guide. Medtronic surgical drills shall only be used through the MAZOR X arm guides, cannulas, and drill guides. Placing Medtronic single-use sterile spheres on each of the NavLock™ Tracker passive stems allow MAZOR X Stealth™ Edition to track the Medtronic instruments in the surgical field.

The document provided describes the CD HORIZON Spinal System Instruments for use with MAZOR X Stealth™ Edition. This is a medical device subject to FDA approval, specifically a 510(k) premarket notification. The document states that the device is substantially equivalent to a predicate device.

The provided text does not contain the detailed information requested regarding specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test or training sets, expert qualifications, or adjudication methods. The information pertains to the regulatory approval process and a general summary of performance testing.

Therefore, many parts of your request cannot be answered from the provided document. I can, however, extract the information that is present.

1. A table of acceptance criteria and the reported device performance

The document does not provide specific quantitative acceptance criteria or reported device performance metrics in the format of sensitivity, specificity, or accuracy, which are typical for AI/diagnostic devices. Instead, it lists general performance tests conducted.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the described tests, nor does it detail the provenance of any data (e.g., country of origin, retrospective/prospective nature). The tests are described as "simulated use" and "analysis" rather than clinical trials with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention using experts to establish ground truth for a test set. The nature of the device (surgical instruments for navigation) suggests performance testing would involve engineering and functional verification rather than expert clinical assessment of diagnostic output.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not mention any adjudication method, as it doesn't describe expert-based ground truth establishment or a review process for a test set in the context of diagnostic performance.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not indicate that an MRMC comparative effectiveness study was done. This device is a set of surgical instruments used with a navigation system (MAZOR X Stealth™ Edition), not typically an AI-powered diagnostic device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This request is not applicable to the device described. The device consists of surgical instruments that are part of a system intended for human use during surgery. It is not an algorithm that can perform standalone diagnostics or analysis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" in the diagnostic sense (e.g., pathology for a diagnosis) is not directly applicable here. The "ground truth" for the performance tests would likely be engineering specifications, physical measurements, and expected functional behavior of the instruments and system. For instance, "Navigation Accuracy Analysis" would involve comparing the navigated position to an objectively measured physical position, which is a form of engineering ground truth.

8. The sample size for the training set

The document does not mention a training set specific to an AI algorithm. This device is a set of physical surgical instruments, not a machine learning model that requires training data.

9. How the ground truth for the training set was established

Not applicable, as no training set for an AI algorithm is mentioned or relevant to this device description.

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Medtronic Navigated Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Instruments are also compatible with the IPC™ POWEREASETM System.

The subject Navigated INFINITY™ drill bit is a sterile, single-use instrument that can be operated manually or under power. This instrument is intended to be used when implanting components of the INFINITY™ OCT System. The Navigated INFINITY™ Drill bit is also compatible with the StealthStation® and IPC® POWEREASE® Systems. Note: The subject devices are not intended to support occipital screw placement.

The provided text does not contain information about acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) premarket notification for "Navigated INFINITY™ Instruments," detailing its indications for use, comparison to a predicate device, and sterilization information.

Specifically, the document states:

• No acceptance criteria or study details: The "Performance Data" section (VII) only mentions "Sterilization" and that "The addition of the sterile drill bit does not create a new 'worst case' and it was adopted in to the existing product family as detailed in the sterilization rationale provided in this submission since the design, material, manufacturing process, and manufacturing facilities of the sterile subject devices are equivalent to that of the referenced product family. The sterilization justification supports an SAL of 10-6. Based on the information provided in this submission, Medtronic believes that adequate evidence has been provided to show that we have fully validated the sterilization parameters." This indicates that the main "performance data" presented is a sterilization justification, not a study with acceptance criteria for device performance.
• Focus on substantial equivalence: The document's goal is to demonstrate substantial equivalence to previously cleared devices, primarily based on identical indications, intended use, technology, materials, dimensions, and design features, with the only technological difference being that the subject device is sterile and single-use, while the predicate was non-sterile and single-use. This type of submission often relies on a comparison to a predicate device rather than extensive new performance studies if the changes are minor and do not introduce new questions of safety or effectiveness.

Therefore, I cannot populate the requested table and information as the necessary details are not present in the provided text.

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Medtronic Navigated Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Instruments are also compatible with the IPC® POWEREASE® System.

The Navigated INFINITY™ Instruments are non-sterile, reusable and single use instruments that can be operated manually or under power. These instruments are intended to be used when implanting components of the INFINITY™ OCT System. The Navigated INFINITY™ Instruments are also compatible with the StealthStation® and IPC® POWEREASE® Systems.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Navigated INFINITY™ Instruments":

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report for new device approval. As such, the information provided for some of your requested points is limited or not applicable in the context of a 510(k).

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document does not specify the sample size (e.g., number of instruments tested, number of simulated cases) for any of the performance tests.
   • Data Provenance: Not specified. Given the nature of a 510(k) and the types of tests listed (simulated use, accuracy analysis, CAD evaluation, functional testing), it is highly probable that the data provenance is retrospective (using internal testing data) and likely in-house laboratory or engineering testing, rather than clinical data from a specific country of origin.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the document. For the types of engineering and functional tests described (e.g., navigation accuracy, instrument functionality, CAD evaluation), "ground truth" would likely be established through engineering specifications, validated measurement systems, and perhaps expert observation from R&D engineers, rather than clinical experts like radiologists.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This information is not provided and is unlikely to be relevant for the non-clinical, performance-based tests described in the 510(k) summary. Adjudication methods like 2+1 are typically used for clinical endpoints, especially in image interpretation.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. The device (Navigated INFINITY™ Instruments) is a surgical navigation instrument, not an AI-powered diagnostic or assistive tool for "human readers." Therefore, this type of study and its associated effect size are not applicable.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The term "standalone" and "algorithm only" are typically used for AI/software devices. This device is a physical surgical instrument that works with existing navigation systems (StealthStation™ System, IPC® POWEREASE® System). The performance tests listed (e.g., Navigation Accuracy Analysis, Anatomical Simulated Use) assess the instrument's accuracy and functionality within the intended surgical navigation system, which inherently involves human interaction (the surgeon). Therefore, a "standalone algorithm only" performance is not applicable in the context of this device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the tests described:
     • Navigation Accuracy Analysis: Ground truth would likely be established through pre-defined engineering specifications and validated measurement systems (e.g., comparing navigated position to physically measured, known positions).
     • Functional/Simulated Use Tests: Ground truth would be defined by the device's design specifications and intended functionality (i.e., whether it performs as designed under various conditions).
     • CAD Model Evaluation: Ground truth would be the original CAD models themselves and the expectation of their accurate representation in the software.
     • No expert consensus, pathology, or outcomes data is explicitly mentioned or seems relevant for these specific engineering tests.

7. The sample size for the training set:

   • This question is not applicable. The "Navigated INFINITY™ Instruments" are physical surgical instruments, not a machine learning model that requires a training set. The underlying navigation systems (StealthStation™) might have calibration data or algorithms, but the instruments themselves do not have a "training set" in the sense of AI.

8. How the ground truth for the training set was established:

   • This question is not applicable as there is no "training set" for these physical instruments.

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The EXPEDIUM Verse System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Verse System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the EXPEDIUM Verse System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM Verse System metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The EXPEDIUM Verse system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM® Verse System is designed to provide intraoperative polyaxial to monoaxial conversion. It facilitates easier rod capture and provides a powerful and precise reduction mechanism. Verse is a reduced profile thoracolumbar implant for use for with wide range of patient statures. EXPEDIUM Verse is a self-contained, efficient, and intuitive instrument system that is compatible with EXPEDIUM 5.5 rods, hooks and mono screws to enhance versatility.

The provided document is a 510(k) premarket notification for the DePuy Synthes Spine EXPEDIUM® Verse Spine System. It describes the device, its intended use, and comparability to predicate devices, but does not contain information related to software or AI algorithms, nor does it provide a study that directly assesses the performance of an AI device against specific acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for AI-related studies.

The document discusses mechanical testing for the physical medical device (spinal implant system), not an AI or software device. The "Non-clinical Test Summary" and "Conclusion" sections refer to these mechanical tests.

To answer your request, I would need a document detailing the performance of an AI-based device, including its acceptance criteria and a study demonstrating its performance.

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